- The Food and Drug Administration is allowing European regulators a more complete look at commercially confidential information linked to pharmaceutical production as part of a newly inked agreement.
- The move furthers a mutual goal among U.S. and European officials to streamline and improve inspections of drug manufacturing facilities. In February, the European Union and the FDA entered a pact in which the two regulatory bodies would trust each other's conclusions from inspections conducted in their respective territories.
- While the EU and U.S. have exchanged commercially confidential information like pharmaceutical trade secrets for more than a decade, the information was never fully complete, according to an Aug. 23 statement from the European Medicines Agency. The new agreement, therefore, "will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health."
The European Commission, EMA and FDA have recently doubled down on efforts to eliminate discrepancies and inefficiencies between the regulatory bodies.
In the past, for instance, a drugmaker would have to undergo FDA inspections of its European manufacturing facilities even if EMA officials had already evaluated them and found no issues.
Such rules caused not only regulatory overlap between the EMA and FDA — and, by extension, wasted time, money and additional resources — but also contributed to general disjointedness between the two agencies. A study published in the New England Journal of Medicine last year found the U.S. regulator green lit more drugs and at a faster clip than its European counterpart between 2011 and 2015.
Naturally, those discrepancies, as well as access to complete sets of data and information, have an affect on what drugs patients in Europe and the U.S. have access to. Eli Lilly & Co. and Incyte Corp.'s baricitinib is just one example of a medicine that has been approved by one agency (in this case the EMA) and rejected by the other.
The latest collaboration around non-public information builds upon earlier work, such as amending the U.S.-EU Mutual Recognition Agreement of 1998, aimed at improving ties between European and stateside regulators, according to the EMA.
"The new confidentiality commitment formally recognises that FDA's EU counterparts have the authority and demonstrated ability to protect the relevant information," the EMA said in an Aug. 23 statement. "This step now allows the sharing of full inspection reports, allowing regulators to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk."